NCT07016477Recruiting
Prospective Registry of Patients Undergoing Cardiac CT With NAEOTOM Alpha PCD-CT Before TAVI Procedure
Prospective Registry of Patients Undergoing Cardiac CT With NAEOTOM Alpha Photon Counting-detector CT Before Transcatheter Aortic Valve Implantation
Source: ClinicalTrials.gov · Last updated 11 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The clinical and demographic characteristics of patients undergoing transcatheter aortic valve implantation (TAVI) pose unique challenges for coronary computed tomography (CT) imaging, as this patient population is mainly composed of elderly, frail individuals with severe aortic stenosis, multiple comorbidities, high prevalence of heavily calcified coronary artery disease (CAD) and revascularized coronary arteries. Such vulnerable patients could benefit from a more precise assessment and characterization of their CAD with ultra-high resolution (UHR) photon-counting detector (PCD) CT that would potentially avoid the need for pre-implantation invasive coronary angiography (ICA). This international multicenter prospective registry study aims to investigate the feasibility and diagnostic accuracy of PCD-CT in the assessment of CAD in the high-risk population of patients undergoing TAVI, as compared to ICA.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1000 (estimated)
- First submitted
- 23 Feb 2025
- Start date
- 1 Jun 2024
- Primary completion date
- 30 May 2029
- Lead sponsor
- Semmelweis University
- Diseases
- Coronary artery disease
- NCT number
- NCT07016477
What you commit to
- Study type: Observational
- Planned participants: 1000
- From 1 Jun 2024 to the primary completion date, 30 May 2029
- 7 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any condition for which TAVI is contraindicated and therefore no prior radiological investigation of TAVI is indicated
Lab values
- Chronic renal failure (eGFR \<30 ml/m2)
Other
- Pregnancy or breastfeeding
- Active oncological treatment
Who the study is looking for
- Clinically indicated TAVI
- Clinically indicated CT and invasive coronary angiography
- There are no contraindications to CT angiography.
- Understanding and signing the consent form
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital of Zurich Coordinator of this site? Confirm its status | Zurich | Switzerland | Not yet recruiting |
| Albert-Ludwigs-Universität Freiburg Coordinator of this site? Confirm its status | Freiburg im Breisgau | Germany | Not yet recruiting |
| University Medical Center Mainz Coordinator of this site? Confirm its status | Mainz | Germany | Recruiting |
| Universitätsklinikum Tübingen Coordinator of this site? Confirm its status | Tübingen | Germany | Not yet recruiting |
| Semmelweis University Coordinator of this site? Confirm its status | Budapest | Hungary | Recruiting |
| Maastricht University Coordinator of this site? Confirm its status | Maastricht | Netherlands | Not yet recruiting |
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.